Expanded Access Programs (EAPs) in Europe
Are they right for your therapy?
By Maximus Rex & Nicola Allen
Drug development is a long and costly process. It is not uncommon for a new drug candidate to take more than 13 years to progress from discovery to being commercially available, w i t h costs often exceeding $1 billion for the manufacturer. For patients with severe conditions with no effective treatment options available, the prospect of waiting for more than a decade before being able to access a medicine that could potentially radically alter disease progression and their quality of life can be devastating. In order to speed up access to medicines that are still in clinical development, various expanded access pathways have been introduced since the first examples were introduced in late 1970s in the United States, and have subsequently been adopted by most major pharmaceutical markets.